Product Liability Attorney Blog

The FDA has authorized a variation on Bayer's successful yet controversial contraceptive Yaz, called Beyaz. In essence, Beyaz is Yaz with a folate supplement included. The additional supplement is intended to raise young ladies' folate levels, which will help prevent a neural tube disorder. Further, the FDA has approved Beyaz for use as an anti-acne medication, pre-menstrual dysmorphic disorder treatment and general contraceptive as an all-in-one package for young women seeking a convenient solution to multiple concerns.

Why, exactly, has this been approved for these purposes while there is still ongoing litigation into the safety of the parent medication? There are a number of cases still pending about the dangers of oral contraceptives such as Yaz and Yasmin. They have been shown in multiple studies to have a link to elevated risk of blood clotting, heart disease and ischemic stroke, so the FDA thinks that the solution is to market them to even more young ladies as a means of correcting a number of things youthful patients see as burdensome?

This isn't a small concern. People have had serious strokes, including attacks that have caused brain damage and long-term suffering. Other patients, particularly those in Canada, have reported that taking elevated levels of these contraceptives has caused gallbladder stones. This painful condition requires the removal of the gallbladder, and surgery is neither pleasant nor cheap.

There is no doubt that the great majority of young ladies take Yaz without serious side effect, and that Beyaz will likely have a similar track record. However, the incidences of elevated blood clotting and risk of stroke or heart conditions when taking Yaz are much more significant than with earlier such drugs in many studies. Further, Bayer has been reprimanded not once but twice for deceptive advertising practices regarding just such medicines. To say that people should be wary would be an understatement.

Levaquin (levofloxacin) is a member of a class of drugs known as flouroquinolones, which are prescribed to fight bacterial infections. The FDA put a "black box" warning on this drug to increase awareness of its link to tendon ruptures and tendonitis.

The FDA warning states that “ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Levofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including levofloxacin."

Signs and Symptoms of a Tendon Rupture

Tendonitis is rip-and-tear damage to a tendon and Levaquin may increase the chance of tendon injuries. The most common injuries reported are tendon ruptures and tendonitis in the shoulder's rotator cuff, the hand and particularly the Achilles' tendon in the foot. Signs and symptoms of tendonitis include swelling and bruising, pain and tenderness near a joint. Movement aggravates these symptoms.

The tendon most frequently associated with Levaquin-induced ruptures is the Achilles tendon in the foot. Signs and symptoms include sudden and severe pain, difficulty in walking and swelling and bruising.

Tendonitis can occur in other tendons, as well; some have well-known names. Tennis elbow — the outer sides of the forearm near the elbow. There is pain when you rotate your forearm or grip an object. Golfer's elbow — pain on the inner part of the elbow. Patellar tendonitis: pain below the kneecap. Adductor tendonitis — pain in the groin. Rotator Cuff tendonitis — shoulder pain.

These tendonitis side affects are a serious consideration if you are prescribed Levaquin. When tendonitis is mild, it can be treated with over-the-counter medications. More severe injuries may require more aggressive treatments.

While the legal wrangling over the safety of antidepressants such as SNRI Effexor and SSRI Paxil has quieted down, another set of lawsuits seems to be popping up relating to these drugs. In the same week that Glaxo Smith Kline was sued for breaching an exclusivity agreement with a manufacturer of a generic form of Paxil, a judge in Israel has more or less dismissed a lawsuit attempting to disrupt pharma company Teva's manufacture of generic Effexor.

Makhteshim-Agan Industries and its child company, Lycored, both filed suit against Teva, alleging that Teva's campaign to make and market generic Effexor XR infringed on a patent that M-A holds. However, while the courts in Israel did see the merit in the case, they dismissed the scale of the claims, only allowing M-A a paltry award of US$2 million.

It may seem a little mad to say “only” $2 million, but such amounts don't even make a dent in the figures of major pharma companies. Glaxo set aside more than $2 billion dollars to deal with litigation against Paxil. M-A originally sought $107 million dollars in damages, not $2 million. Before the housing bubble burst, some townhouses in Washington, D.C., were selling for $2 million dollars. This “award” is basically a saving-face arrangement — nothing more.

Teva made headlines with the massive scale of its entry into the generic drug market. The company is expected to make $650 million dollars during its exclusive period to market Effexor XR's generic form, and it used two jumbo jets to transport and market its newly-available medication once it had the right to begin selling. The stakes involved here make the award judges granted M-A entirely irrelevant, and will allow Teva officials to go forward without any sense of interruption or even inconvenience as they market this powerful, controversial antidepressant.

After weeks of relative quiet, news indicates that some of the increasing lawsuits against the makers of Levaquin are going forward. This week, a conference was held to discuss matters pertinent to the assorted cases, as well as about how best to proceed.

There were a number of matters discussed at the meetings, and reports reveal the courts and the litigants are all taking the matter very seriously. The first bellwether trial for Levaquin toxicity is set to take place in approximately 60 days. Additionally, interested parties spoke of scheduling a second bellwether case as well, which indicates neither party wishes to rely solely on the outcome of a single case. In fact, there are approximately six such bellwether cases pending in total, though scheduling has only been discussed for these first two.

Also on review are the terms of the cases in general, as well as a number of as-yet unaddressed or outstanding motions relating to the various cases.

Bellwether cases are a common occurrence in very large lawsuits such as this. There are well over a thousand cases currently pending against the makers of Levaquin, with every indication that more will be filed as time passes. A bellwether case is one that is used to test public and legal opinion on a matter. The way that the bellwether cases go will shape the assorted litigants' opinions about how to continue.

If the result seems favorable to the manufacturers, they likely will push forward with efforts to have the cases tried in court or dismissed. On the other hand, if the juries seem sympathetic to the litigants and offer large penalty awards, then the defendants may seek to offer settlements out of court. This is the pattern of events that largely took place in the recent Paxil lawsuits, where Paxil's makers settled for several billion dollars after losing important bellwether cases.

Often the story surrounding a drug and its effects goes further than the specific studies related to that drug alone. News has been relatively quiet lately about Paxil and the lawsuits continually being filed against its maker, GlaxoSmithKline. However, to assume that quiet means nothing is happening is to miss the bigger picture. GSK continues to deal with accusations of dishonesty in general, and a company's overall pattern of behavior can be used to build a more complete understanding of the situation. After all, if a company is being dishonest about one type of drug, what's to say it isn’t being dishonest about another?

There has been some recent furor about GSK's once-touted diabetic medicine, Avandia. Prior to 2007, GSK was very quiet about the specific results of its clinical trials and medical studies pertaining to this drug. Lawsuits, however, forced the company to disclose the findings, and in 2007 the New England Journal of Medicine published results showing that GSK had discovered the link between Avandia and myocardial infarctions but had kept a lid on the matter.

Now three years later, the British Medical Journal has published further findings that cast even more bizarre light on the matter. In short, the article found that GSK and publications at the time all were culpable in what amounted to a cover-up of the drug's dangerous symptoms. Avandia was a new and unique way to control diabetes, because it took away the need to constantly poke oneself with needles. Because of this potential benefit and desirability, people in positions to do so downplayed the few, short term studies that to date had only shown inconclusive results, rather than demand longer term studies that would play the matter out more accurately.

The exact degree of culpability is a matter for the courts to decide. However, this kind of information should give anyone in a position to trust GSK pause before extending that trust again.

There is often more to a drug's story than the legal battles fought over it. For example, consider this (link) article from the Jamaica Observer. The article does not go into the legal battles surrounding modern birth control, but simply presents the basic pros and cons of several pill-based contraceptives young ladies might wish to consider — among them Bayer's Yasmin.

The article illustrates clearly just how little information is publicly available or openly discussed about the drug's failings. The article mentions that Yasmin could help relieve bloating, but possibly have more side effects such as nausea. That's really it; the section on Yasmin doesn't address the other very serious side effects that have been discussed, such as increased blood clotting leading to heart damage or stroke, or the potential for high cholesterol leading to gall bladder disease such as gallstones and possible gall bladder removal.

This isn't to say the article does not address blood clotting at all. Down at the end of it, it does mention that blood clots are among the side effects of any form of birth control pill. However, it doesn't explain what it means by blood clots. There is no explanation of the role of blood clots in causing ischemic strokes and brain damage, or of a clot going to the lungs and causing a collapse. Nor is there any discussion of the numerous studies that suggest Yasmin (and its sister medication, Yaz) have a greater potential for causing blood clot than other drugs of their type.

Perhaps a simple article discussing the relative merits of various contraceptives isn't the place to have a major medical battle. However, there are hundreds of lawsuits active in the United States and Canada pertaining to the potential side effects of Yasmin and Yaz. As long as the information about these drugs remains scarce, young women will continue to receive limited accounts that do not explain the whole story.

During the same week that a generic formulation of the oral contraceptive Yasmin was approved, several new lawsuits were filed against Bayer, the original producers of the drug. Once again, the suits focus on the lack of information and the general disinformation provided by Bayer to patients concerning the risks and truths about this contraceptive, which is alleged to cause thickened blood, blood clots and ischemic stroke.

The first suit was filed in Cincinnati, Ohio. The plaintiff in this case has alleged that the documentation provided for Yasmin's sister drug, Yaz, was inconsistent and scattered. Warnings would be buried deep inside the paperwork while other facts were repeated pointlessly in numerous places. A second lawsuit that was filed in Canada alleged much the same thing. Both also are asserting that the documents did too little to explain the risk of potential blood clots and damages that could be caused by taking these oral contraceptives for too long. Furthermore, the Canadian plaintiff is suing for actual damages relating to a stroke she suffered — a stroke she claims was caused by taking Yasmin. In addition, she suffered gallstones during the treatment cycle, requiring her gallbladder to be removed.

More than 2,000 lawsuits have been filed against Bayer and its distributors to date for just the above reasons.

And yet despite the continuing rate of lawsuits being filed, the FDA has elected to approve a generic formulation of Yasmin, to be produced under the name Zarah. The Abbreviated Drug Application was approved earlier last week, allowing Watson Laboratories to go forward with the manufacture and eventual sale of the generic drug, which is fundamentally identical to Bayer's contraceptive, carrying the same risks and side effects that its parent drug has.

There is no way to phrase this without wondering exactly what the FDA is thinking: Why go forward and approve a generic form of Yasmin at a time when the very safety of the drug is still being called into question?

If there was any doubt in people's minds that Yasmin and its cousin Yaz are incredibly profitable, it should be laid to rest at this point. Watson Laboratories just received permission from the FDA to manufacture and sell a generic formulation of the oral contraceptive under the brand name Zarah.

So, what exactly does this mean for consumers?

At the chemical level, Zarah contains the same active ingredients as Yasmin (drospirenone and ethinyl estradiol). This means that it will perform the same function as Bayer's contraceptive, which has been proven very effective at preventing pregnancies when taken as directed. However, this means it will also carry with it all of the same side effects as the parent drug: blood clotting risks and the chance of increasing the risk of strokes and heart infarctions.

The proliferation of generic drugs is, by and large, a good thing. They increase the availability of a drug in the market, which lowers prices and allows consumers more opportunity to get the medicine they want. They also create competition between companies for these clients, encouraging each company to provide the best quality and access.

However, it also means that the risks of the medicine are increased overall. More quantity of the medicine means more access, and when people find out there are generic versions of a drug available, they unconsciously believe that this means the drug must be safe — after all, the FDA approved the medicines for general use, right? They make generic acetaminophen that's just as good as the name brand stuff, isn’t it?

These attitudes demonstrate the lack of understanding about the FDA's role in things. As a regulatory body, it can't force testing that creates zero-risk results, nor should it. However, this also means that risky medicines such as Yaz and Yasmin get onto the market and lead to lawsuits and health complications that could be avoided, and the wisdom of allowing a generic version of a contested drug to go forward must always be questioned.

Tardive Dyskinesia continues to be a rather irritating fly in the ointment for the makers of the gastrointestinal drug Reglan. Reglan was developed as a high-end version of recent over-the-counter medications used to treat heartburn. Capable of treating the most stubborn cases of the condition as well as persistent nausea, Reglan is a very useful tool in alleviating patient distress. However, there are increasing concerns that its use may be dramatically outweighed by its risks, particularly since many doctors seem unable to abide by the packaging warnings explaining the nature of Tardive Dyskinesia.

Studies indicate that up to 20 percent of Reglan prescriptions go beyond the 12-week prescription guidelines. This seems natural enough; some acid reflux conditions are incredibly persistent and require continuous medical intervention to manage. However, documentation by the FDA indicates that the chance of Tardive Dyskinesia goes up in relation to both the amount of medicine prescribed and the duration of exposure to the medicine. Still, a typical prescription for Reglan is four 10-mg pills per day for weeks, if not months, on end. This is a more or less constant degree of exposure to the medicine.

Further, there's the fact that Tardive Dyskinesia has no known cure and frequently is permanent. While the condition is potentially able to resolve itself and desist without any long-term damage, it is just as likely to stick around and leave the patient without recourse: Not only do they have to discontinue the medical treatment that may have been the only relief they could find, they now are subject to uncontrollable muscle spasms and ticks in their extremities.

Many of the lawsuits filed against the makers of Reglan and its generic derivatives have focused on the lack of information available. There are plenty of cases of warning literature out there, but they are apparently being kept out of patients' hands, leading many to wonder just what the remaining value of prescribing Reglan is.

In this 2003 article, we learn that the FDA, America's government body with a mandate to make sure there is at least some level of oversight to the quality and safety of medications being prescribed to the American populace, has warned against the use of Paxil in young children. The warning followed a similar announcement by British medical authorities, both groups citing an increased risk of the drug prompting suicidal thoughts or behaviors in younger patients. We also see that Paxil is not approved for the treatment of Major Depressive Disorder in any patient under the age of 18; although literal age is not at all significant in medical guidelines, there has to be a line drawn somewhere, and the FDA has chosen this one to warn about.

Now consider this article, which brings to light a series of tests that Glaxo is performing by prescribing Paxil to patients as young as 7 years old. The difference? They're performing the tests in Japan, which has a different series of regulations about medical tests.

Now, the FDA has not outright banned the prescription of Paxil to young patients. Indeed, in the first article they stressed that young children already on Paxil should not abruptly stop taking it, due to other risks and complications associated with abrupt cessation of treatment. So, why does Paxil feel the need to test their medicine in another country, instead of here in the United States? Why are they testing on patients so young?

The second article also raises other questions. The risk of suicidal thoughts is well-documented already, it doesn't need further proof. Yet the test is only comparing Paxil against a placebo, not against other drugs. All this will do is further confirm the suicidal tendencies related to the medication, and nothing else. After all, Paxil is an effective antidepressant and can contribute to elevated mood — this is already known.

Just what is this apparently ill-advised test meant to accomplish, after repeated warnings about this medicine's effects in young children from several government groups?

The primary focus of current lawsuits against Bayer for its popular birth control pill Yaz has been the medication’s potential to cause increased blood clotting, a side effect that has been alleged to cause heart damage and strokes in a number of patients. However, certain new cases being filed against Bayer have been alleging that the pill also is causing damage to patients' gallbladders, in some cases resulting in the removal of said organ. While it is true someone can live without their gallbladder, the organ plays an important role in managing the presence of oils in the body, and having surgery to remove it is an expensive and painful option that no one should be forced to bear needlessly.

The suits, several having originated in Canada, allege that Bayer's birth control pill is disrupting the hormone levels in women's bodies, leading to a rise in cholesterol in the bile that the gallbladder regulates. This results in reduced function in the bladder, which allows hard deposits to form, eventually causing gallstones. Gallstones are an intensely uncomfortable and painful condition, with many patients reporting them as more painful than kidney stones; the pain is often so intense that it requires strong medication to bring under control.

Gallstones also cause infection in the gallbladder through the irritation they cause. These infections require strong antibiotic treatments to eliminate, and must be controlled before surgery can happen. A laparoscopy, the procedure to remove the gall bladder, can be a difficult process to recover from as well, though it is generally not a risky surgery.

In short, if the link between taking Yaz and the irritation of the gallbladder to the point of gallbladder disease can be established, Bayer will continue to have difficulty insisting that this high-earning medicine is just as safe as other forms of birth control.

As we’ve discussed previously, timing is a very important matter when dealing with Reglan cases. It is widely understood at this point that Reglan directly causes Tardive Dyskinesia. However, it still is difficult for some doctors to make the link between the two because of the term “tardive” in its name. “Tardive” means that the condition has a delayed onset, not beginning immediately with the prescription of medication. Delays can range from several days to several weeks, and the severity of symptoms can vary tremendously between small and barely noticed facial ticks to near complete loss of muscular control in the extremities.

Because of this, some Reglan patients aren't even diagnosed with Tardive Dyskinesia immediately. Doctors periodically make other diagnoses, such as Parkinson's or various other movement disorders. This delay in reaching the proper diagnosis can be dangerous for the patient. Tardive Dyskinesia has no known treatment at this time, and while many cases do resolve themselves, some end up being permanent. Further, it is known that longer exposure to Reglan and its derivatives causes more severe cases, and is more likely to result in permanent or long-term symptoms compared to shorter exposures.

Additionally, this unique situation leads to questions about the statute of limitations. The specific time limits imposed by statute vary between jurisdictions, and it isn't always clear whether the statute starts from the time the medicine was prescribed, from the first onset of symptoms or from the proper diagnosis with TD. If the onset of symptoms is used as a benchmark, but the patient spent several months under the impression he had Parkinson's, then he is already behind the curve on the matter and might not have enough time to get all his paperwork in order. This is a serious matter, so anyone diagnosed with TD should act immediately to determine his or her standing in the case before the narrow limit runs out.

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